Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.
- Your 6 Priority Areas For A Successful 2024
- 6 PEG Alternatives You Should Be Thinking About
- A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time
- Achieving Flexibility In RNA Drug Manufacturing With Microfluidics
- Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
- Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
- A Cell Therapy Company’s “Unpopular” Internal Manufacturing
6 PEG Alternatives You Should Be Thinking About
PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.
A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time
This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.
Achieving Flexibility In RNA Drug Manufacturing With Microfluidics
RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.
Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?
Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
A Brief Introduction To Environmental Monitoring For Startups
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
Why Lactococcus Lactis Might Be The Best Membrane Protein Factory
The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.
Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
PHARMA OUTSOURCING WHITE PAPERS
A Molecule’s Journey: Break Down Roadblocks To Clinical Success
The key to a biopharma executive's success is making the right decisions at the right time. Which will get your biologic to the clinic quickly and cost-effectively, without compromising quality and patient safety?
A Five-Point Strategy For Building A CMC Dossier
By adopting strategies to build a robust CMC package to help streamline the path to FIH trials, innovators can establish a quality foundation to support their path toward commercialization.
Making The Right Decisions Upstream To Ensure Downstream Success
Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.
Revolutionizing Particle Characterization With Image Analysis And ML
The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.
Reducing Risk During CAR T Cell Therapy Development And Manufacture
It is essential to identify potential areas for optimization early in CAR T cell therapy development—particularly with respect to equipment, reagents, and analytics.
Key Stages In mRNA-Based Therapeutic Development
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
More women are entering and making significant gains in our drug development and manufacturing outsourcing sector. In this e-book, Chief Editor Louis Garguilo highlights a few of these individuals, and takes account of the current environment for women who do enter our industry.More Content Collections